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Management of LUTS by Community Pharmacists

Primary Purpose

Lower Urinary Tract Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pharmacist review of LUTS
Pharmacist Provision of healthy aging leaflets
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥60 years
  • Report lower urinary tract symptoms (LUTS)
  • Read and communicate in English

Exclusion Criteria:

  • Age ≤ 59 years
  • Deny LUTS
  • Refuse to consent
  • Unavailable or unable to participate in follow-up visits

Sites / Locations

  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pharmacist Intervention

Control

Arm Description

Pharmacist assessment of LUTS, with recommendations and education regarding lifestyle, behaviour, and/or medications related to bladder health. Follow-up at 3 and 6 weeks.

Pharmacist questions regarding presence of LUTS, with provision of healthy aging literature. Follow-up at 6 weeks.

Outcomes

Primary Outcome Measures

Change in Patient Perception of Bladder Condition (PPBC)
Questionnaire to assess patient perception of LUTS severity Scored from 1-6; 1 = problems, 6=severe problems

Secondary Outcome Measures

Change in Bladder Self-Assessment Questionnaire (B-SAQ)
Self-administered questionnaire to assess types of symptoms and extent of bother Scored for Bother 0-12; 0=no bother, 12 = bothers a great deal Scored for Symptoms 0-12; 0=no symptoms, 3=severe symptoms
Change in International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF)
Self- administered questionnaire to describe extent and severity of LUTS Scored from 0-21; 0= no impact or leakage; 21 = severe leakage and interference

Full Information

First Posted
March 23, 2020
Last Updated
June 23, 2023
Sponsor
University of Alberta
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04331340
Brief Title
Management of LUTS by Community Pharmacists
Official Title
A Project to Address Lower Urinary Tract Symptoms (LUTS) by Pharmacists in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many older adults have urinary incontinence. They often seek treatments, such as diapers, pads, or medications, from the community pharmacy. Pharmacists are trained to assist seniors with therapies that treat urinary incontinence. Our study will determine how much benefit there is if pharmacists try to provide more assistance for seniors with incontinence. Over a period of months, half of the people who talk to the pharmacist about their incontinence will be given general information about health and aging. The other half of the people will have a longer assessment and complete a questionnaire with the pharmacist. Then the pharmacist will call and have a follow-up visit to see how the incontinence symptoms have improved. We will compare both groups to see whose symptoms were improved.
Detailed Description
This randomized controlled trial is designed to determine the effect of a pharmacist intervention to manage lower urinary tract symptoms (LUTS) in the community. The objectives of the study are to determine the effect of the pharmacist as measured by the Patient Perception of Bladder Condition (PPBC) (primary objective), the Bladder Self-Assessment Questionnaire (B-SAQ), and the International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF) (as secondary objectives). The pharmacists at community pharmacies will be recruited through the networks already established within Alberta for pharmacy practice research, and the Pharmacists Association of Alberta. The pharmacists must have advanced prescribing authorization with their professional license. The patients will be recruited with the posting of shelf-talkers by the incontinence and menstrual products section of the pharmacy and with leaflets in prescription bags. If a patient obtains a LUTS product or if the patient presents him/herself in response to the shelf-talker, the pharmacist will screen the patient to determine if LUTS are present.The patients will be eligible to participate if they are at least 60 years of age, report LUTS, can communicate in English, and provide consent. The patient will be randomized to either a control or intervention. Those assigned to the control group will be eligible to receive the intervention following the follow-up period. Both the control and intervention group will have a baseline PPBC, B-SAQ, and ICI-Q-SF questionnaires, in addition to demographics and a medical history. The control group will receive a healthy aging pamphlet and will be called back at 8 weeks to have the questionnaires repeated. The intervention is based on the published guide for LUTS for pharmacists (Gabriel, et al. 2015). The pharmacist will assess the patient's LUTS and determine an appropriate intervention plan, which may include education, lifestyle, behavioural, or medication modification. The patient will be given a summary of the plan and the primary care provider will also receive a summary. At 4 weeks the patient will be contacted by phone or in person (per patient preference), with a review of the plan and repeated bladder questionnaires. At 8 weeks the patient will complete the final interaction with the pharmacist and will complete the bladder questionnaires for the final time. The primary outcome is the change in PPBC from baseline to 8 weeks, and secondary outcomes include the change from baseline until 8 weeks in the B-SAQ, ICI-Q, and health system use (including referrals to physicians, specialists, and pharmacist billing). We plan to enroll 100 patients (50 in each group). All analyses will be by intention to treat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist Intervention
Arm Type
Experimental
Arm Description
Pharmacist assessment of LUTS, with recommendations and education regarding lifestyle, behaviour, and/or medications related to bladder health. Follow-up at 3 and 6 weeks.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Pharmacist questions regarding presence of LUTS, with provision of healthy aging literature. Follow-up at 6 weeks.
Intervention Type
Other
Intervention Name(s)
Pharmacist review of LUTS
Intervention Description
Pharmacist review and recommendations, including education, behaviour, lifestyle, or medications
Intervention Type
Other
Intervention Name(s)
Pharmacist Provision of healthy aging leaflets
Intervention Description
Pharmacist will inquire about presence of LUTS and provide patient with healthy aging leaflets
Primary Outcome Measure Information:
Title
Change in Patient Perception of Bladder Condition (PPBC)
Description
Questionnaire to assess patient perception of LUTS severity Scored from 1-6; 1 = problems, 6=severe problems
Time Frame
Change from baseline to 8 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in Bladder Self-Assessment Questionnaire (B-SAQ)
Description
Self-administered questionnaire to assess types of symptoms and extent of bother Scored for Bother 0-12; 0=no bother, 12 = bothers a great deal Scored for Symptoms 0-12; 0=no symptoms, 3=severe symptoms
Time Frame
Change from baseline to 8 weeks post-intervention
Title
Change in International Consultation on Incontinence Module Questionnaire Short Form (ICI-Q-SF)
Description
Self- administered questionnaire to describe extent and severity of LUTS Scored from 0-21; 0= no impact or leakage; 21 = severe leakage and interference
Time Frame
Change from baseline to 8 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥60 years Report lower urinary tract symptoms (LUTS) Read and communicate in English Exclusion Criteria: Age ≤ 59 years Deny LUTS Refuse to consent Unavailable or unable to participate in follow-up visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl A Sadowski, Pharm.D.
Phone
7804925078
Email
cherylas@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl A Sadowski, Pharm.D.
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1C9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl A Sadowski, Pharm.D.
Phone
7804925078
Email
cherylas@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Yazid Al Hamarneh, PhD
Phone
780-492-9608
Email
yazid.alhamarneh@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Subject demographics and scores of the primary and secondary outcomes measures will be shared at all time points.
IPD Sharing Time Frame
After completion of the study in 2021, for 5 years.

Learn more about this trial

Management of LUTS by Community Pharmacists

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